Executive Summary: British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids

Russell, Mark; Dey, Mrinalini; Flint, Julia; Davie, Philippa; Allen, Alexander; Crossley, Amy; Frishman, Margreta; Gayed, Mary; Hodson, Kenneth; Khamashta, Munther A.; Moore, L.A.; Panchal, Sonia; Piper, Madeleine; Reid, Clare; Saxby, Katherine; Schreiber, Karen; Senvar, Naz; Tosounidou, Sofia; Venne, Maud van de; Warburton, Louise; Williams, David; Yee, Chee-Seng; Gordon, Caroline; Giles, Ian; Roddy, Ed; Armon, Kate; Astell, Lauren; Cotton, Caroline; Davidson, Alan; Fordham, Sarah; Jones, Claire; Joyce, Christopher; Kuttikat, Anoop; McLaren, Zoe; Merrison, Karen; Mewar, Devesh; Mootoo, Amanda; Williams, Emma

doi:10.1093/rheumatology/keac558

Cited by 10 publications

(9 citation statements)

References 12 publications

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“…Die Leitlinien umfassen zusätzlich die Themen Kontrazeption, reproduktionsmedizinische Behandlung, Fertilitätserhalt bei gonadotoxischen Therapien, Schwangerschaftsberatung und -management sowie Arzneimitteltherapie von Männern mit ERE, die eine Vaterschaft planen [18]. Die zur Zeit aktuellsten Empfehlungen liegen von der britischen Gesellschaft für Rheumatologie vor [19,20]. Sie geben einen Überblick zu antirheumatischen Therapien in Schwangerschaft und Stillzeit sowie zu Arzneimitteln zur Behandlung von Komorbiditäten.…”

Section: Infobox 2: Nationale Und Internatio Nale Leitlinienunclassified

Was erwartet mich und mein Kind?

Meißner

2024

Arthritis und Rheuma

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ZUSAMMENFASSUNGDie Entscheidung, eine Familie zu gründen, stellt Frauen mit entzündlich-rheumatischen Erkrankungen (ERE) vor Herausforderungen, die solche von Frauen ohne chronische Krankheit übersteigen. Das Spannungsfeld zwischen der eigenen und der kindlichen Gesundheit kann zu Konflikten und emotionalen Belastungen führen. Die rheumatische Grunderkrankung nimmt eine wesentliche Rolle in der Entscheidungsfindung rund um Kinderwunsch und Schwangerschaft ein. Krankheitsverlauf und -management und die Auswirkung der ERE auf die Schwangerschaft sind Themen, die Betroffene beschäftigen. Die stärksten Ängste der Frauen im Hinblick auf die Schwangerschaft stehen im Zusammenhang mit der Arzneimitteltherapie und dem potenziellen Risiko, die embryonale oder fetale Entwicklung negativ zu beeinflussen. Betroffene schätzen die Sicherheit von Medikamenten oft anders ein als die rheumatologisch betreuenden Ärzt*innen. Hinzu kommt, dass Gynäkolog*innen häufig ebenfalls keine Erfahrung mit rheumatischen Erkrankungen und deren Therapien haben. Aus diesen Gründen haben rheumatisch erkrankte Frauen einen erheblichen Bedarf an individuellen, umfassenden und aktuellen Informationen rund um Schwangerschaft und Geburt vor dem Hintergrund ihrer Grunderkrankung, der oftmals nicht ausreichend gedeckt wird. Sorgen und Ängste sollten ein wesentlicher Bestandteil der individuellen Beratung von Frauen mit ERE sein, die schwanger werden wollen oder bereits schwanger sind. Informierte Frauen haben bessere Chancen, die komplexen Herausforderungen einer Schwangerschaft trotz ihrer chronischen Erkrankung zu meistern.

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Section: Infobox 2: Nationale Und Internatio Nale Leitlinienunclassified

Was erwartet mich und mein Kind?

Meißner

2024

Arthritis und Rheuma

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“…Safety data regarding the existing rheumatologic biologics during pregnancy are limited by the exclusion of pregnant patients in drug trials and limited post marketing data. We have the most information regarding pregnancy exposure of TNFα inhibitors, due to their extensive use in both rheumatic diseases and in persons with inflammatory bowel disease [21,22 ▪▪ ]. Interpretation of data is confounded by the fact that disease activity itself can impact pregnancy outcome.…”

Section: Potential To the Fetus And Newborn Due To Biologics Usementioning

confidence: 99%

“…For example, while one study found an increased risk for preterm birth and small for gestational age births [23] with TNFα use during pregnancy, the authors concluded that these were associated more with underlying disease activity than the therapeutic agent. Generally, studies have not found evidence to support significant immunosuppression by TNFα inhibitors since there is no observed increase in infection rates in exposed infants, regardless of whether exposure occurred early or late in pregnancy [22 ▪▪ ,24]. Overall, the recommendation from rheumatologic societies is to continue TNFα inhibitors throughout pregnancy and transiently hold them during the third trimester, if the underlying disease is well controlled [22 ▪▪ ,25,29,30,38,39,40 ▪ ,41,42,43 ▪ ,44] (Table 2).…”

Section: Potential To the Fetus And Newborn Due To Biologics Usementioning

confidence: 99%

Safety of biologic agents for the management of rheumatic diseases during pregnancy

D’Gama,

Bermas

2024

Current Opinion in Rheumatology

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Purpose of review To discuss the current understanding regarding the use of biologic therapeutics in pregnancy. Recent findings Our understanding of the mechanisms underlying the potential fetal and infant exposure to biologics as well as a growing body of empirical evidence from real world use of biologics in pregnancy have demonstrated that biologics are generally compatible preconception and during pregnancy. Long-term effects of exposure to biologic agents in utero are not known, but will be uncovered in time. Biosimilars, which are becoming more popular, may not always share the same safety profiles as their originators. Summary Biologics have revolutionized the management of rheumatologic disease and ushered in a new era of clinical remission among patients. These agents, developed and introduced into clinical use at the beginning of the new millennium, are very potent, yet their efficacy in treating disease often in reproductive aged women, raises questions regarding their safety during pregnancy. These therapeutics can cause immunosuppression and can inhibit immunologic circuits that are not only involved in disease pathophysiology but hypothetically could impact the development of the fetal immune system. Reassuringly, biologics, typically antibodies or antibody-based proteins, are introduced to the fetus via the typical route of transplacental antibody transfer, and thus only begin to be transferred in appreciable amounts in the second trimester (after organogenesis). From theoretic and empirical standpoints, biologic use during pregnancy appears well tolerated for fetal development and to not substantially affect infant immune development.

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“…The 2020 ACR and 2022 British Society for Rheumatology guidelines classify Leflunomide as "incompatible" with pregnancy and recommend discontinuing it at least 24 months before attempting to conceive (Russell et al, 2023;Sammaritano et al, 2020). Most of the information on the teratogenic effects of Leflunomide comes from animal models where exposure to a high dose during conception reduced fetal viability and increased the risk of fetal malformations (Fukushima et al, 2007).…”

Section: Introductionmentioning

confidence: 99%

Leflunomide exposure through second trimester of pregnancy: A case report

Alothman,

Yeung,

Waterman

et al. 2023

Birth Defects Research

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Leflunomide is a commonly used disease modifying antirheumatic agent. However, its use is contraindicated in pregnancy. The American College of Rheumatology (ACR) guidelines recommend discontinuing Leflunomide at least 24 months before conception. If a woman is found to be pregnant while on Leflunomide, ACR suggests close monitoring and cholestyramine washout. We describe a case of a patient with a history of juvenile idiopathic arthritis who was on Leflunomide throughout the first and second trimester of her pregnancy. A cholestyramine washout regimen was started but not completed. The patient was induced at 37 weeks of gestation due to non‐reassuring fetal heart rate. She ultimately delivered a healthy baby via emergency cesarian section.

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Executive Summary: British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids

Abstract: NICE has accredited the process used by BSR to create its clinical guidelines. The term began on 27 February 2012 and the current renewed accreditation is valid until 31 December 2023. More information on accreditation can be viewed at www.nice.org.uk/accreditation.

Cited by 10 publications

References 12 publications

Was erwartet mich und mein Kind?

Was erwartet mich und mein Kind?

Safety of biologic agents for the management of rheumatic diseases during pregnancy

Leflunomide exposure through second trimester of pregnancy: A case report

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